Bedford Laboratories has announced a national (US) voluntary product recall of acetylcysteine solution manufactured for Roxane Laboratories. The recall was initiated on December 20, 2011 due to a visible glass particle in a vial of solution from lot 1877093. According to the company, no adverse events have been reported.
The company warned that “Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased clearance of airway secretions).” Patients who received product from the lot in question are advised to return the vial to their pharmacist.
Bedford Laboratories is a subsidiary of Ben Venue Laboratories, which is a subsidiary of Boehringer Ingelheim.
Acetylcysteine shortages due to manufacturing problems have been a recurring problem. According to the FDA drug shortages website, Roxanne Laboratories is unable to provide an anticipated release date for new product, American Regent is releasing product sporadically, and Hospira will not be shipping product until April.
Read the Bedford Laboratories press release.
